A 3-part study in healthy male volunteers to assess the safety and tolerability of the test medicine TQS-168 and how it is taken up by the body when given as single and multiple doses

A Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-, Ascending-Dose Study of the Safety, Tolerability and Pharmacokinetics of TQS-168 in Healthy Male Adults

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46651459

Enrollment

Registered

2021-10-05

Start date

2021-06-09

Completion date

Unknown

Last updated

2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and tolerability of the test medicine TQS-168 Not Applicable

Interventions

The study consists of a single (Part 1, SAD cohort) and multiple-dose (Part 2, MAD cohort) escalation. In Part 1 using a computer-generated randomisation schedule, subject numbers wil

the first 2 subjects in each cohort (the sentinel group) will be randomised in a 1:1 ratio between TQS-168 suspension formulation or placebo. The remaining subjects (main group) will then be allocated

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy male subjects 2. Aged 18 to 55 years inclusive at the time of signing informed consent 3. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening 4. Weight =55 kg at screening 5. Must be willing and able to communicate and participate in the whole study 6. Must provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1 2. Subjects who are, or are immediate family members of, a study site or sponsor employee 3. Parts 1 and 2 Only: Subjects who have previously been administered IMP in this study 4. Evidence of current SARS-CoV-2 infection 5. History of any drug or alcohol abuse in the past 2 years 6. Regular alcohol consumption >21 units per week (1 unit = pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)

Design outcomes

Primary

Measure	Time frame
To provide safety and tolerability information for TQS-168 by assessing: 1. Adverse events (AEs) measured using subject interviews, physical examination at throughout the study 2. Vital signs measured using Oral temperature at screening and pre-dose. Oral temperature, BP, HR and Respiratory rate at screening, pre-dose and at 1, 2 and 24, 36 and 48 hours post-dose for the SAD cohorts and for MAD cohorts oral temperature, RR, BP and HR at pre-dose, 1 hour, 2 hour and 4 hour post-dose on days 1 to 7 (treatment period) and at 24, 36 and 48 hour after last dose. 3. Electrocardiograms (ECGs) measured at screening, pre-dose and at 1, 2 and 24, 36 and 48 hours post-dose for the SAD cohorts and for MAD cohorts at pre-dose, 1 hour, 2 hour and 4 hour post-dose on days 1 to 7 (treatment period) and at 24, 36 and 48 hour after last dose 4. Physical examinations measured at screening, pre-dose, 24 and 48 hours post-dose and at follow-up visit 10 to 14 days post-dose for the SAD cohorts; For MAD cohorts at screening, pre-dose and 48-hours after last dose (day 9) and at follow-up visit 10 to 14 days following last dose. Targeted symptom driven physical examination will be performed as clinically indicated as per investigator judgement for both SAD and MAD cohorts. 5. Laboratory safety tests: For SAD cohorts, safety labs – haematology, clinical chemistry and urinalysis will be performed at screening, pre-dose and 48 hours after dosing and at follow-up visit 10 to 14 days following dosing. For MAD cohorts, safety labs – haematology, clinical chemistry and urinalysis will be performed at Screening, pre-dose on days 1, 2 and 7 and at 24 and 48 hour after the last dose on day 7 and at the follow-up visit 10 to 14 days following the last dose.	—

Measure

Time frame

To provide safety and tolerability information for TQS-168 by assessing: 1. Adverse events (AEs) measured using subject interviews, physical examination at throughout the study 2. Vital signs measured using Oral temperature at screening and pre-dose. Oral temperature, BP, HR and Respiratory rate at screening, pre-dose and at 1, 2 and 24, 36 and 48 hours post-dose for the SAD cohorts and for MAD cohorts oral temperature, RR, BP and HR at pre-dose, 1 hour, 2 hour and 4 hour post-dose on days 1 to 7 (treatment period) and at 24, 36 and 48 hour after last dose. 3. Electrocardiograms (ECGs) measured at screening, pre-dose and at 1, 2 and 24, 36 and 48 hours post-dose for the SAD cohorts and for MAD cohorts at pre-dose, 1 hour, 2 hour and 4 hour post-dose on days 1 to 7 (treatment period) and at 24, 36 and 48 hour after last dose 4. Physical examinations measured at screening, pre-dose, 24 and 48 hours post-dose and at follow-up visit 10 to 14 days post-dose for the SAD cohorts; For MAD cohorts at screening, pre-dose and 48-hours after last dose (day 9) and at follow-up visit 10 to 14 days following last dose. Targeted symptom driven physical examination will be performed as clinically indicated as per investigator judgement for both SAD and MAD cohorts. 5. Laboratory safety tests: For SAD cohorts, safety labs – haematology, clinical chemistry and urinalysis will be performed at screening, pre-dose and 48 hours after dosing and at follow-up visit 10 to 14 days following dosing. For MAD cohorts, safety labs – haematology, clinical chemistry and urinalysis will be performed at Screening, pre-dose on days 1, 2 and 7 and at 24 and 48 hour after the last dose on day 7 and at the follow-up visit 10 to 14 days following the last dose.

—

Secondary

Measure	Time frame
PK for TQS-168: For SAD cohorts PK samples are collected at pre-dose, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hour post-dose. For MAD cohorts PK samples are collected at following timepoints: Day 1 at pre-dose, and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16 and 24-hour post-dose Day 2 to Day 6 at 2, 4, 24-hours post-dose Day 7 at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose	—

Measure

Time frame

PK for TQS-168: For SAD cohorts PK samples are collected at pre-dose, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hour post-dose. For MAD cohorts PK samples are collected at following timepoints: Day 1 at pre-dose, and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16 and 24-hour post-dose Day 2 to Day 6 at 2, 4, 24-hours post-dose Day 7 at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026