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A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Adimistration in Healthy Subjects

A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Adimistration in Healthy Subjects

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038126
Enrollment
Unknown
Registered
2020-09-11
Start date
2020-10-09
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

HBV

Interventions

Part A:Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.
Part B:Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Male or female subjects aged 18-50 years (including 18 and 50 years old); 2. Body mass index (BMI) = body weight (kg) / height 2 (M2), with body mass index (BMI) in the range of 18-28 kg / m2 (including the critical value); 3. Subjects (including partners) voluntarily took effective contraceptive measures within 6 months from screening to the last administration of the trial drug.

Exclusion criteria

Exclusion criteria: 1. Patients with abnormal clinical laboratory examination or the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases) with clinical significance within 12 months before screening; 2. Subjects of allergic constitution (allergy to various drugs and foods); 3. Patients with alcohol history; 4. Subjects who have taken any prescription drug, over-the-counter drug, any vitamin product or Chinese herbal medicine within 14 days before screening; 5. Subjects who have taken any drugs to change the activity of liver drug enzymes within 30 days before screening, such as barbiturates and rifampicin; 6. Subjects who have taken the following inhibitors or inducers of P-gp, BCRP, OATP1B1, OATP1B3, OAT1, Oat3 or MRP4 within 30 days before screening, such as azithromycin, pantoprazole or St. John's wort; 7. Female subjects were in lactation or blood pregnancy during screening period, and the results were positive.

Design outcomes

Primary

MeasureTime frame
Cmax;AUC;AE;

Countries

China

Contacts

Public ContactLin Luo

Sunshine Lake Pharma Co.Ltd

luolin@hec.cn+86 769 8531 5888-2535

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026