## Protocol Section
### Identification Module
**NCT ID:** NCT06431438

**Brief Title:** Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets

**Official Title:** A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets

#### Organization Study ID Info
**ID:** TQA3810-I-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2023-11-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-20

**Type:** ACTUAL

#### Start Date
**Date:** 2021-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study was a single-center study, including randomized, double-blind, placebo-controlled, single-dose escalation study, multiple-dose study, food effect on pharmacokinetics and drug metabolism transformation study, drug interaction study. To evaluate the tolerability, pharmacokinetics and metabolic transformation of TQA3810 in healthy subjects after single or multiple doses of TQA3810, the drug-drug interactions between TQA3810 tablets and entecavir dispersible tablets, and the pharmacokinetic properties of TQA3810 tablets in combination.

### Conditions Module

**Conditions:**

- Chronic Hepatitis B

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 759

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

**Intervention Names:**

- Drug: TQA3810

**Label:** 0.5mg single-dose

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

**Intervention Names:**

- Drug: TQA3810

**Label:** 1.0mg single-dose

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Description:** Sixteen subjects were enrolled and all received the trial drug.

**Intervention Names:**

- Drug: TQA3810

**Label:** Food impact group

**Type:** OTHER

#### Arm Group 4

**Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

**Intervention Names:**

- Drug: TQA3810

**Label:** 0.1mg single-dose

**Type:** PLACEBO_COMPARATOR

#### Arm Group 5

**Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

**Intervention Names:**

- Drug: TQA3810

**Label:** 0.3mg single-dose

**Type:** PLACEBO_COMPARATOR

#### Arm Group 6

**Description:** Sixteen subjects were enrolled and all received the trial drug.

**Intervention Names:**

- Drug: TQA3810

**Label:** Drug interaction group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 7

**Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

**Intervention Names:**

- Drug: TQA3810

**Label:** 0.1mg multiple dosing

**Type:** PLACEBO_COMPARATOR

#### Arm Group 8

**Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

**Intervention Names:**

- Drug: TQA3810

**Label:** 0.3mg multiple dosing

**Type:** PLACEBO_COMPARATOR

#### Arm Group 9

**Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

**Intervention Names:**

- Drug: TQA3810

**Label:** 0.5mg multiple dosing

**Type:** PLACEBO_COMPARATOR

#### Arm Group 10

**Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

**Intervention Names:**

- Drug: TQA3810

**Label:** 0.2mg multiple dosing

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 0.1mg multiple dosing

- 0.1mg single-dose

- 0.2mg multiple dosing

- 0.3mg multiple dosing

- 0.3mg single-dose

- 0.5mg multiple dosing

- 0.5mg single-dose

- 1.0mg single-dose

- Drug interaction group

- Food impact group

**Description:** TQA3810 is a small-molecule Toll-like receptor (TLR8) agonist

**Name:** TQA3810

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded.

**Measure:** Incidence of Adverse Events

**Time Frame:** From the subject signed the informed consent form to 30 days after the last dose

#### Secondary Outcomes

**Description:** Maximum plasma drug concentration

**Measure:** Cmax

**Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

**Description:** To maximum plasma drug concentration time.

**Measure:** Tmax

**Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

**Description:** Drug half-life in plasma.

**Measure:** Half-life (t1/2)

**Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

**Description:** Plasma drug concentration from time 0 to the last measurable area under the drug concentration time curve.

**Measure:** AUC0-t

**Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

**Description:** Area under the plasma drug concentration time curve from time 0 to infinity.

**Measure:** AUC0-∞

**Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
* Able to complete the study according to the requirements of the trial protocol;
* The participants (including their partners) are willing to voluntarily use effective contraceptive methods within 6 months from screening until the last dose of study drug, as detailed in the Appendix;
* Male and female subjects aged 18-55 years old (including 18 and 55 years old);
* The body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 18-28 kg/m2 (including the cut-off value);
* The physical examination and vital signs were normal or abnormal without clinical significance.

Exclusion Criteria:

* Smoking more than 5 cigarettes per day in the 3 months before the study;
* Allergic constitution (multi-drug and food allergy);
* A history of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 ml wine);
* Donation or massive blood loss (\> 400 mL) within 3 months before screening;
* Taking any drugs that alter liver enzyme activity 28 days before screening;
* Have taken any prescription medication, over-the-counter medication, any vitamin product or herbal medicine within 14 days before screening;
* Those who had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 2 weeks before screening, or had other factors affecting drug absorption, distribution, metabolism, and excretion;
* Combined with the following inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or dronedarone, within three months before taking the study drug;
* A recent major change in diet or exercise habits;
* Have taken a study drug or participated in a clinical trial of the drug within three months before taking the study drug;
* A history of dysphagia or any gastrointestinal disorder affecting drug absorption or a history of cholecystectomy or biliary tract disease;
* Have any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers;
* With severe systemic diseases and related medical history (including subjects with active or occult tuberculosis, a history of tuberculosis, or clinical manifestations suspected of tuberculosis), as well as immune system diseases and medical history;
* Had systemic or local infection within 2 months prior to screening, and were hospitalized for severe infection and/or required intravenous antibiotics;
* Subjects who were unable to tolerate a standard meal;
* An electrocardiogram (ECG) abnormalities have clinical significance;
* The female subjects were lactating or seropositive for pregnancy during the screening or test period;
* Clinically significant abnormalities on clinical examination or other clinical findings within 6 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, oncologic, pulmonary, immune, psychiatric, or cardio-cerebrovascular diseases);
* Clinically significant fundus lesions (symptomatic cotton-like fundus changes) and retinopathy;
* Viral hepatitis (including hepatitis B and C), AIDS antibody, treponema pallidum antibody positive;
* From the screening stage to the onset of acute illness or concomitant medication before study medication;
* Consumption of chocolate, any caffeinated or xanthine-rich food or beverage 24 hours before taking the study drug;
* Have taken any alcohol-based product within 24 hours before taking the study medication;
* Having a positive urine drug screen or having a history of drug abuse or drug use in the past 5 years;
* Subjects with other factors considered by the investigator to be ineligible for the trial.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nanjing

**Country:** China

**Facility:** Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

**State:** Jiangsu

**Zip:** 210008

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006505

- Term: Hepatitis

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000018347

- Term: Hepadnaviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000006521

- Term: Hepatitis, Chronic

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: LOW

- As Found: Unknown

- ID: M9591

- Name: Hepatitis

- Relevance: LOW

- As Found: Unknown

- ID: M9595

- Name: Hepatitis B

- Relevance: HIGH

- As Found: Hepatitis B

- ID: M21609

- Name: Hepatitis B, Chronic

- Relevance: HIGH

- As Found: Chronic Hepatitis B

- ID: M9607

- Name: Hepatitis, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20487

- Name: Hepadnaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006509

- Term: Hepatitis B

- ID: D000019694

- Term: Hepatitis B, Chronic

### Misc Info Module

- Version Holder: 2024-05-31
