Phase 1 Pharmacokinetics, Safety, and Tolerability Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04067947

Enrollment

Registered

2019-08-28

Start date

2019-07-08

Completion date

2020-02-10

Last updated

2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

DRUGXG005

XG005 Tablet

DRUGPlacebos

Placebo Tablet

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

The Investigator or designee, study coordinator(s), subjects, the Sponsor study team and its representatives, will be blinded to the treatment assignment.

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026