A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: ALG-097558; Drug: Placebo; Drug: ALG-097558 in solution formulation; Drug: Carbamazepine; Drug: Midazolam; Drug: ALG-097558 in tablet formulation; Drug: Itraconazole

• Registration Number: NCT05840952
• Lead Sponsor: Aligos Therapeutics

Brief Summary

A multi-part study of ALG-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-05-03
• Study Start: 2023-07-04
• Primary Completion: 2024-04-29
• Study Completion: 2024-04-29
• Status Verified: 2024-09
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALG-097558	ALG-097558	Oral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days
Placebo	Placebo	Oral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days
ALG-097558 and Carbamazepine	Carbamazepine	Oral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers
ALG-097558 and Midazolam	Midazolam	Oral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers
ALG-097558, Placebo, and, Itraconazole	ALG-097558	Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers.
ALG-097558 Bioavailability	ALG-097558 in solution formulation	Oral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers
ALG-097558, Placebo, and, Itraconazole	Itraconazole	Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers.
ALG-097558 Bioavailability	ALG-097558 in tablet formulation	Oral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers
ALG-097558, Placebo, and, Itraconazole	Placebo	Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers.
ALG-097558 and Midazolam	ALG-097558	Oral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers
ALG-097558 and Carbamazepine	ALG-097558	Oral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers

Primary Outcome Measures

Name	Time	Method
C0 [predose]	Predose (-0.75 hours) up to 9 days	Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Half-life [t1/2]	Predose (-0.75 hours) up to 9 days	Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 17 days for Part 6	The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Area under the concentration time curve [AUC]	Predose (-0.75 hours) up to 9 days	Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Maximum plasma concentration [Cmax]	Predose (-0.75 hours) up to 9 days	Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Time to maximum plasma concentration [Tmax]	Predose (-0.75 hours) up to 9 days	Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Minimum plasma concentration [Cmin]	Predose (-0.75 hours) up to 9 days	Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet

Secondary Outcome Measures

Name	Time	Method
Minimum plasma concentration [Cmin]	Predose (-0.75 hours) up to 19 days	Pharmacokinetic parameters of ALG-097558 in plasma
Time to maximum plasma concentration [Tmax]	Predose (-0.75 hours) up to 19 days	Pharmacokinetic parameters of ALG-097558 in plasma
Half-life [t1/2]	Predose (-0.75 hours) up to 19 days	Pharmacokinetic parameters of ALG-097558 in plasma
C0 [predose]	Predose (-0.75 hours) up to 19 days	Pharmacokinetic parameters of ALG-097558 in plasma
Dose Proportionality	Predose (-0.75 hours) up to 19 days	Pharmacokinetic parameters of ALG-097558 in plasma
Maximum plasma concentration [Cmax]	Predose (-0.75 hours) up to 19 days	Pharmacokinetic parameters of ALG-097558 in plasma
Area under the concentration time curve [AUC]	Predose (-0.75 hours) up to 19 days	Pharmacokinetic parameters of ALG-097558 in plasma

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom