Phase 1 Pharmacokinetics, Safety, and Tolerability Study

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Placebos; Drug: XG005

• Registration Number: NCT04067947
• Lead Sponsor: Xgene Pharmaceutical Group

Brief Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.

Detailed Description

This is a randomized, double-blind, placebo-controlled study which will investigate the PK, safety, and tolerability of four ascending single and multiple oral doses of XG005 in healthy subjects. The trial consists of two parts: a single ascending dose (SAD) PK evaluation (Part 1) and a multiple ascending dose (MAD) PK evaluation (Part 2). Approximately 32 Subjects will be enrolled sequentially into a total of 4 ascending dose levels in each part.

Study Timeline

• Study Start: 2019-07-08
• Status Verified: 2019-08
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-28
• Primary Completion: 2019-12-03
• Study Completion: 2020-02-10
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Healthy males or females between 18 and 55 years of age
2. BMI 18.0 to 30.0 kg/m2
3. Non-pregnant, non-breastfeeding female subjects

Exclusion Criteria

1. Unstable or severe illness
2. History of, or current treatment for, GI disease
3. Clinically significant history of medical condition associated with GI events
4. History of or current glucose intolerance or gestational diabetes
5. Lifetime history of suicidal behavior
6. Creatinine clearance < 90 mL/min
7. Any elevation of liver function tests
8. Creatine kinase (CK) value of greater than 1.5 times the upper limit
9. Leucocytes or lymphocytes less than 1.5 times the lower limit of normal
10. Positive Hepatitis B surface antigen, HCV, or HIV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Placebo in all cohort
XG005	XG005	XG005 in 4 dose levels

Primary Outcome Measures

Name	Time	Method
Adverse Event related to XG005	Day 1 to 7 days after last dose	Adverse Event reported as mild, moderate, severe on physical exam, ECG and laboratory results

Trial Locations

Locations (1)

Linear Clinical Research Ltd; 🇦🇺 Nedlands, Western Australia, Australia