NCT06280534

Safety, Tolerability Phase Ia Study of XT1061 in Single and Multiple Doses in Healthy Subjects

Randomized, Double-blind, Single Center Phase Ia Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Double-Blind, Single-Center Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects.

Detailed description

This trial is a randomized, double-blind, dose-escalation, placebo-controlled, single-center clinical study designed to evaluate the safety, tolerability, pharmacokinetic profile and metabolic conversion of XT1061 in healthy subjects with single and multiple administrations, as well as a study of the effect of food on pharmacokinetics.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	Test drug XT1061 capsules and placebo,Single dose group	Eight people took capsules of the test drug XT1061 and two people took a placebo.
DRUG	Test drug XT1061 capsules and placebo，Multiple dosing group	D1-D7 were administered under fasting conditions for 7 consecutive days, of which D1-D6 were administered BID and D7 was administered once in the morning under fasting conditions only.Eight people took capsules of the test drug XT1061 and two people took a placebo.
DRUG	Test drug XT1061 capsules and placebo，Food Impact Group	Eight people in group A took the test drug XT1061 capsules and two people took placebo, and all eight people in group B took the test drug XT1061 capsules.

Timeline

• Start date: 2023-07-18
• Primary completion: 2024-02-29
• Completion: 2024-03-31
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

1 site across 1 country: China