NCT03993704

Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants

A Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of LHF-535 (LHF-535-SDD) in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Kineta Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a daily oral dose of LHF-535 administered for 14 days to healthy participants.

Detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of orally administered LHF-535 in 24 to 32 healthy adult participants. Three successive escalating cohorts, each containing 8 participants, are planned. Within each cohort, 6 participants will be randomized to receive an oral dose of LHF-535 once daily for 14 days, and 2 will be randomized to receive an oral dose of placebo once daily for 14 days. After a screening period of up to 28 days, all participants will be confined to the study center from 1 day prior to dosing until at least 24 hours after the 14th day of dosing. Participants will return for follow-up evaluations on Day 17 and Day 21 (72 and 168 hours after last dose, respectively) and on Day 42. After each cohort, safety data through Day 17 and PK data through Day 7 will be reviewed by a blinded Safety Committee prior to dosing of the next cohort. The Safety Committee is charged with making one of the following three recommendations: (1) proceed with dose escalation as planned, (2) continue the study with modification (e.g., proceed with the next cohort at a lower dose level than planned), or (3) suspend the study. An additional cohort of 8 participants may be added to evaluate dosing for future studies, at the discretion of the Sponsor, in consultation with the Safety Committee.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LHF-535	Oral suspension administered once daily for 14 days

Timeline

• Start date: 2019-09-16
• Primary completion: 2020-01-09
• Completion: 2020-06-09
• First posted: 2019-06-21
• Last updated: 2020-07-09

Locations

1 site across 1 country: Australia