## Protocol Section
### Identification Module
**NCT ID:** NCT05667779

**Brief Title:** A Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants

**Official Title:** A Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose, First in Human Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants

#### Organization Study ID Info
**ID:** QRL-101-01
#### Organization
**Class:** INDUSTRY
**Full Name:** QurAlis Corporation
#### Secondary ID Infos
**ID:** 2022-002484-30
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2023-12-27

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-15

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-27

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-22

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2022-12-29
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-19
**Study First Submit QC Date:** 2022-12-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** QurAlis Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 in male and female healthy participants. The findings from this study will be used to inform the development of QRL-101 for people living with ALS.

**Detailed Description:** Phase 1, single-site study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 administered orally in healthy male and female participants. Up to 16 cohorts of 8 participants each, randomized 6:2 (QRL-101: placebo) will be tested. The approximate total duration of study participation for each participant may be up to 40 days.

### Conditions Module

**Conditions:**

- Healthy Volunteers

**Keywords:**

- Healthy Volunteers

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study will be a randomized, double-blind, placebo-controlled single ascending dose (SAD) study in healthy participants with the primary goal of evaluating the safety and tolerability of QRL-101.

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** A participant and investigator-blinded, randomized, placebo-controlled design will be used to minimize bias in this study.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 88

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Single-ascending doses of QRL-101 will be administered orally to healthy participants

**Intervention Names:**

- Drug: QRL-101

**Label:** QRL-101

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Single-ascending doses of comparator placebo will be administered orally to healthy participants

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- QRL-101

**Description:** Single-ascending doses of QRL-101 will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data.

**Name:** QRL-101

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** A placebo comparator will be administered at all dose levels.

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Endpoints: A summary of treatment emergent adverse events (AEs), serious adverse events (SAEs), and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.

**Measure:** Number of participants with one or more treatment emergent adverse events and serious adverse events.

**Time Frame:** Baseline through Follow up (Day 10)

#### Secondary Outcomes

**Description:** Endpoint: Maximum observed concentration (Cmax) of QRL-101

**Measure:** Pharmacokinetics (plasma): Maximum observed concentration of QRL-101

**Time Frame:** Baseline through Follow up (Day 10)

**Description:** Endpoint: Area under the concentration time curve from zero to infinity (AUC 0-24h) of QRL-101

**Measure:** Pharmacokinetics (plasma): Area under the concentration time curve from 0 to 24 h (AUC 0-24h) of QRL-101

**Time Frame:** Baseline through Follow up (Day 10)

**Description:** Endpoint: Time of maximum concentration (Tmax) of QRL-101

**Measure:** Pharmacokinetics (plasma): Time of maximum concentration of QRL-101

**Time Frame:** Baseline through Follow up (Day 10)

### Eligibility Module

**Eligibility Criteria:** INCLUSION CRITERIA

1. Age 18 to 70 years of age inclusive at the time of signing the informed consent.
2. Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
3. Body mass index of 18 to 32 kg/m2 (inclusive).
4. Willing and able to practice effective contraception.

EXCLUSION CRITERIA

1. Currently enrolled in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
2. Any participant in \>4 studies a year and/or has participated in a clinical trial within 1 month of expected dosing date.
3. History or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.

\*Other inclusion and exclusion criteria may apply\*

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Groningen

**Country:** Netherlands

**Facility:** ICON plc. Van Swietenlaan 6

**Zip:** 9728 NZ

#### Overall Officials

**Official 1:**

**Affiliation:** ICON plc

**Name:** Salah Hadi, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
