Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers

Samjin Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SA001 360mg or Placebo; Drug: SA001 720mg or Placebo; Drug: SA001 1,080mg or Placebo; Drug: SA001 240mg + Rebamipide 200mg or Placebo; Drug: SA001 710mg + Rebamipide 600mg or Placebo; Drug: SA001 480mg or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05303961

SJSA001_02

Details and patient eligibility

About

This study consists of Part 1 followed Part 2.

Part 1 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and active comparator(Rebamipide) in healthy male volunteers.

Part 2 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of multiple oral dose of SA001 in healthy male volunteers.

Full description

Part 1(Single dose, dose escalation study, SA001 240mg~1,080mg dose group)

The starting dose is SA001 240mg, and the maximum dose is 1,080mg. Each dose group is assigned to Experimental group (SA001 or SA001 + Active Comparator(Rebamipide)) or Placebo group in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a single oral administration.

Part 2 (Multiple dose, dose escalation study, SA001 360mg~1,080mg dose group)

The starting dose is SA001 360mg, and the maximum dose is 1,080mg. Each dose group is assigned to SA001 or Placebo in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a multiple oral administration.

Enrollment: 56 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 19 years to 45 years (Healthy male Korean)
2. Body weight of 55 to 90kg; and BMI of 18.0 to 27.0 kg/m2
3. Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study

Exclusion criteria

1. Subject with a disease history of any clinically significant condition as below.

   • Liver, Kidney, nervous system, immune system, respiratory system, endocrine system, tumor, cardiovascular disease or mental illness (mood disorder or obsessive-compulsive disorder etc.) etc.

2. Subject with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the study drug

3. Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)

4. Serum ALT(SGPT)/AST(SGOT) >1.5×institutional upper limit normal (ULN)

5. eGFR< 90mL/min/1.73m2

6. Systolic blood pressure <100 mmHg or >160 mmHg

7. Diastolic blood pressure <60 mmHg or >100 mmHg

8. Inadequate cardiac function confirmed by 12-lead ECG findings at screening as followings:

   • QTcF > 430msec (males)
   • PR interval > 200msec or < 110msec
   • QRS complex > 120msec
   • Evidence of 2nd- or 3rd-degree atrioventricular (AV) block
   • Pathologic Q waves (defined as Q-wave > 40msec or depth > 0.5mV)
   • Evidence of ventricular preexicitation, left bundle branch block (LBBB), right bundle branch block (RBBB, Incomplete RBBB)

9. Subject with risk factors for Torsade de pointes such as long QT syndrome, family history of sudden death, heart failure, hypokalemia, and arrhythmias

10. Subject with a history of drug abuse within 60 days prior to screening or who is positive for drugs of abuse in urine tests at screening

11. Subject who received any drugs such as

    • Prescription drug or herbal medicine within 14 days prior to the first administration of the investigational products
    • Over the counter (OTC) or vitamin within 7 days prior to the first administration of the investigational products

12. Subject who received other investigational products within 90 days prior to the first administration of the investigational products

13. Subject who have donated whole blood within 60 days prior to the first administration of the investigational products, or donated component blood or have received blood transfusion within 30 days prior to the first administration of the investigational products

14. Subject who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol during the study period

15. Subject with history of smoking within 90 days prior to the first administration of the investigational products

16. Subject who cannot prohibit grapefruit/ caffeine-containing foods during the study period from 3 days before the first administration of the investigational products

17. Man of reproductive potential not willing to use contraceptive measures during the study period

18. Subject not eligible for study participation in the opinion of the investigator

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 3 patient groups, including a placebo group

SA001

Experimental group

Description:

Part 1: 24 subjects are assigned to single dose groups(240mg, 480mg, 720mg, 1080mg of SA001) in a ratio of 1:1:1:1 and receiving each dose of SA001 in the period 1. Part2: 18 subjects are assinged to multiple dose groups(360mg, 720mg, 1080mg of SA001) in a ratio of 1:1:1 and receiving each dose of SA001.

Treatment:

Drug: SA001 1,080mg or Placebo

Drug: SA001 720mg or Placebo

Drug: SA001 360mg or Placebo

Drug: SA001 240mg + Rebamipide 200mg or Placebo

Drug: SA001 710mg + Rebamipide 600mg or Placebo

Drug: SA001 480mg or Placebo

Drug: SA001 1,080mg or Placebo

Rebamipide

Active Comparator group

Description:

Part 1: 12 subjects are assigned to single dose groups(200mg, 600mg of Rebamipide) in a ratio of 1:1 and receiving each dose of Rebamipide in the period 2.

Treatment:

Drug: SA001 240mg + Rebamipide 200mg or Placebo

Drug: SA001 710mg + Rebamipide 600mg or Placebo

Placebo

Placebo Comparator group

Description:

Part 1: 8 subjects receiving a single dose of Placebo in the period 1. Part2: 6 subjects receiving multiple dose of Placebo.

Treatment:

Drug: SA001 1,080mg or Placebo

Drug: SA001 720mg or Placebo

Drug: SA001 360mg or Placebo

Drug: SA001 240mg + Rebamipide 200mg or Placebo

Drug: SA001 710mg + Rebamipide 600mg or Placebo

Drug: SA001 480mg or Placebo

Drug: SA001 1,080mg or Placebo