NCT04993443

First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036

A Single and Multiple-dose Escalation First-in-Human Study Evaluating the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Administered Via Inhalation and IV Infusion in Healthy Subjects and Patients With Mild Asthma.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is Phase I first-in-human trial evaluating the safety, tolerability, immunogenicity, and pharmacogenomics of LQ036 via inhalation and IV infusion. The study will be divided into 4 parts: Single Ascending Dose, Multiple Ascending Dose, and Intra Venous with a target of 88 healthy volunteers and 30 patients with mild Asthma.

Detailed description

This study will be a Multicenter, phase Ia/Ib, randomized, double-blind, placebo controlled, Single Ascending Dose(SAD)/ Multiple Ascending Dose (MAD) study of dose escalation cohorts evaluating the safety, tolerability, immunogenicity, and PK of LQ036 after administration via inhalation and intravenous (IV) infusion in healthy subjects and patients with mild Asthma. The study will be divided into 4 parts: The four parts will be completed sequentially or with partial overlapping. Part A - SAD Cohorts (A1 to A5): A staggered dosing schedule will be followed, for each cohort: 2 sentinel subjects (1 active and 1 placebo) will be dosed and the remaining 6 subjects will be dosed no sooner than the next day. Cohorts will be dosed sequentially in an ascending fashion. There will be at least 14 days between dosing of each dose level. Following completion of each dose level, a safety review committee (SRC) composed by at least the Investigator, a Sponsor representative, and an Independent Medical monitor will review the safety and tolerability data, as well as available PK and immunogenicity data up to Day 15, for at least 6 subjects in the respective cohort, as well as available PK and immunogenicity data. Decisions from the SRC may include whether to escalate to the next dose level, continue with a more conservative approach (slowing the increase in dose or repeating a dose level), suspending dose escalation until further review of study data, stopping dose escalation, or terminating the study. Part B - MAD Cohorts (B1 to B4): Part B can be initiated only following review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4, if deemed acceptable by the SRC. A staggered dosing schedule may be used for the first dose level, including 2 sentinel subjects (1 active and 1 placebo) initiating dosing first and the remaining 6 subjects initiating dosing no sooner than the next day. Cohorts will be dosed sequentially in an ascending fashion. There will be at least 14 days between dosing of each dose level. Following completion of each dose level, a SRC composed of at least the Investigator, a Sponsor representative, and an Independent Medical monitor will review the safety and tolerability data up to Day 15, for at least 6 subjects in the respective cohort, as well as available PK and immunogenicity data. Decisions from the SRC may include whether to escalate to the next dose level, continue with a more conservative approach (slowing the increase in dose, repeating a dose level, or exploring an alternative dosing regimen), suspending dose escalation until further review of study data, stopping dose escalation, or terminating the study. Part C - IV Cohorts (C1 and C2): Part C can be initiated only following review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4, if deemed acceptable by the SRC. A staggered dosing schedule will be followed for each cohort: 2 sentinel subjects (1 active and 1 placebo) will be dosed first and the remaining 6 subjects will be dosed no sooner than the next day. Cohorts will be dosed sequentially in an ascending fashion. There will be at least 14 days between dosing of each dose level. Following completion of each dose level, The SRC composed by at least the Investigator, a Sponsor representative, and an Independent Medical monitor will review the safety and tolerability data up to Day 15, for at least 6 subjects in the respective cohort, as well as available PK and immunogenicity data. Decisions from the SRC may include whether to escalate to the next dose level, continue with a more conservative approach (slowing the increase in dose or repeating a dose level), suspending dose escalation until further review of study data, stopping dose escalation, or terminating the study. Some alterations from the currently outlined dose and/or dosing regimen may be performed, but the dose to be administered in a given cohort will not exceed the one currently outlined in the protocol. Part D (Multiple Dose Patients) - Cohorts D1 to D3: Part D may be initiated following submission and review of an interim analysis report from Parts A through C of the study by both the SRC and Human Research Ethics Committee (HREC). Part D may commence only after approval to commence from both committees is granted. A staggered dosing schedule may be used for each cohort. Two (2) sentinel subjects (1 active and 1 placebo) will initiate dosing first (a minimum of 1 hour apart from end of dosing for first sentinel patient to start of dosing for second sentinel patient) and the remaining 8 subjects will initiate dosing no sooner than the next day (each dosed at least 15 minutes apart from end of dosing for previous patient to start of dosing for following patient). Cohorts will be dosed either sequentially or with partial overlapping and the SRC will meet to discuss relevant data collected after completion of at least the first cohort.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	LQ036	For Each part of the study, a staggered dosing schedule may be used for the first dose level, in each cohort including 2 sentinel subjects (1 active and 1 placebo) initiating dosing first and the remaining 6 subjects for Part A-C and 8 subjects for Part D initiating dosing no sooner than the next day. Each study part (A, B, C, and D) will be completed sequentially, but with partial overlapping. Part B and C may only be initiated after review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4. Part D may be initiated when safety tolerability and PK data are known and deemed acceptable by the SRC for multiple doses in Part B, at least at the same concentration to be administered in Part D.
OTHER	Matching Placebo	Matching Placebo for LQ036: Matching Placebo

Timeline

• Start date: 2021-09-06
• Primary completion: 2023-03-02
• Completion: 2023-03-09
• First posted: 2021-08-06
• Last updated: 2023-04-13

Locations

2 sites across 1 country: Australia