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

NCT06280534 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Xi'an Xintong Pharmaceutical Research Co.,Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2024-02-29
Completion
2024-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06280534 on ClinicalTrials.gov