A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562

A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Subcutaneous HTL0022562 in Healthy Adult Subjects

Phase 1, randomised, double-blind, first in human, two part, single centre, placebo controlled, single and multiple ascending dose trial in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: HTL0022562

Detailed Description

This is a first in human, two part, double blind, placebo controlled, randomised single and multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.

Part 1 comprises of 7 sequential ascending dosing cohorts and Part 2 comprises of 4 multiple ascending dosing cohorts.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Parexel Early Phase Clinical Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Healthy males or healthy females (WoNCBP) aged 18 to 55 years inclusive, with a body mass index 18.5-30kgm2 and body weight less than 50kg.
• Healthy on the basis of a clinical history, physical examination, electrocardiogram (ECG), vital signs and laboratory tests of blood and urine.
• Willingness to comply with requirements or the trial, including contraception requirements.
• Able to give fully informed consent.

Key Exclusion Criteria:

• Confirmed current COVID 19 infection before randomisation.
• Clinical signs and symptoms consistent with COVID 19 (e.g. fever, dry cough, dyspnoea, sore throat, or fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening or on admission.
• Suffered from severe course of COVID 19 (ECMO, mechanically ventilated).
• Receipt of any IMP in a clinical research study within the previous 3 months (or 5 half-lives, whichever is longer) of Screening.
• Any abnormalities on 12-lead ECG or BP at Screening (as specified).
• History of any drug or alcohol abuse in the past 2 years.
• Vital signs outside the normal range for healthy volunteers
• Clinically significant abnormal biochemistry, haematology, coagulation, or urinalysis
• Abnormal renal function, hepatic function or history of abnormal hepatic function occurring during treatment with investigational or licensed drugs, which led to permanent discontinuation of treatment.
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV), or human immunodeficiency virus (HIV)
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, or current hepatic renal dysfunction as judged by the investigator.
• Risk factor for ischaemic heart disease or cerebrovascular disease.
• Failure to satisfy, in the Investigator's judgement, the subject's fitness to participate for any other reason, including previous serious adverse reaction or serious hypersensitivity reactions to any drug or formulation excipients administered parenterally or orally.
• All female subjects must have a negative serum and urine pregnancy test at Screening and admission, respectively.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Single Ascending Dose; Eight subjects in up to 7 cohorts will be dosed. One or more subcutaneous injections of HTL0022562 will be administered. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.	Drug: Placebo; Placebo; Drug: HTL0022562; HTL0022562
Experimental: Part 2 Multiple Ascending Dose; Eight subjects in up to 4 cohorts will be dosed, following safety, tolerability and PK review of completed dose of Single Ascending Dose Cohort 5. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.	Drug: Placebo; Placebo; Drug: HTL0022562; HTL0022562

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment Emergent Adverse Events (TEAEs)	All AEs, including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations, local tolerability and site injection reactions, and ECGs will be analyzed in all subjects.	Screening up to post last dose: Day 8 (Part 1) / Day 15 (Part 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and Part 2: Cmax	Plasma pharmacokinetic parameter: maximum systemic concentration of HTL0022562	Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Tmax	Plasma pharmacokinetic parameter: time to Cmax of HTL0022562 Plasma pharmacokinetic parameter: time to Cmax of HTL0022562	Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Area Under Curve (AUC)	Plasma pharmacokinetic parameter: Area under the plasma concentration versus time curve derived from systemic concentrations of HTL0022562	Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Ae	Urine pharmacokinetic parameter: Amount of HTL0022562 recovered in urine for each urine collection interval	Part 1 up to Day 8, Part 2 up to Day 15

Collaborators and Investigators

• Sponsor: Heptares Therapeutics Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Actual): November 23, 2021
• Study Completion (Actual): November 23, 2021

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: First in Human; Single Ascending Dose; Multiple Ascending Dose
• Other Study ID Numbers: HTL0022562-101; 2020-002887-30 (EudraCT Number); 246780 (Other Identifier: Parexel Early Phase Clinical Unit London)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No