Phase 1 Pharmacokinetics, Safety, and Tolerability Study

Xgene Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Placebos; Drug: XG005

Study type: Interventional

Funder types: Industry

Identifiers

NCT04067947

XG005-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

XG005

Experimental group

Description:

XG005 in 4 dose levels

Treatment:

Drug: XG005

Placebo

Placebo Comparator group

Description:

Placebo in all cohort

Treatment:

Drug: Placebos