Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis

Artivila (Shenzhen) Innovation Center, Ltd

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: ARD-885 Placebo Tablet; Drug: ARD-885 Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07266207

KHZY-ARD885-001

Details and patient eligibility

About

The proposed study is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetic, and food effects of ARD-885 Film-coated Tablets in healthy subjects.The entire study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study in healthy subjects.

Full description

The whole study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study. The SAD and MAD studies are randomized, double-blinded, and placebo-controlled studies, and the FE study is a randomized, open-label, two-period, two-treatment (2×2) crossover study.

Enrollment: 94 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All subjects:

  1. Healthy male and female subjects of any ethnic origin between the ages of 18 and 55. Male and female patients with rheumatoid arthritis between the ages of 18 and 70.
  2. An informed consent document signed and dated by the subject. Subjects must be willing to understand and comply with all research procedures and restrictions and be able to communicate effectively with investigators.
  3. A minimum body weight of 50 kg for males and 45 kg for females, with a body mass index of 18 to 28 kg/m2 for healthy subjects and 18 to 35 kg/m2 for patients with RA.
  4. Subject (including partner) agrees to use at least one effective contraceptive method during sexual activity with partner from screening until 3 months after dosing agrees not to participate in sperm or egg donation during the study period until 3 months after the last dosing. See Section 8.1 for specific contraceptive methods.

Exclusion criteria

1. Known or suspected allergy to any component of ARD-885 Film-coated Tablets, or individuals with a hypersensitivity to allergies (multiple drug and food allergies), as determined by the investigator, and deemed unsuitable for inclusion.
2. Lactating women; Women of reproductive age with menstrual disorders within 90 days before administration; Women of childbearing age who have had unprotected sexual intercourse with an opposite-sex partner in the 28 days before administration. Female subjects who are lactating or have a positive serum pregnancy result during the screening period or during the trial.
3. Participated in any drug clinical trial within 90 days before administration, or the administration date of this study is still within the safety washout period specified in the previous drug clinical trial.
4. Non-physiological blood loss ≥ 200 ml within 60 days before administration (including trauma, blood collection, blood donation); Or plan to donate blood during the trial or within 30 days of administration.
5. Had a major disease that investigators considered clinically significant within 90 days before first administration; Have any active malignancy or history of malignancy in the 5 years prior to screening, with the exception of treated and considered cured skin squamous or basal cell carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ.
6. Had major surgery within 60 days of administration, or had any surgery within 28 days of administration.
7. Infectious diseases such like fever and so on within 28 days before administration.
8. Previous use of any of the drugs or treatments listed in protocol.
9. Received vaccine or live attenuated vaccine within 1 month before administration, or who plan to receive the vaccine during the trial period.
10. Those who smoked more than 5 pieces of tobacco or equivalent daily in the 3 months before screening, or drank ≥ 14 units of alcohol per week; Or disagree with the prohibition of smoking or alcohol during the trial; Or positive alcohol serum test during screening or baseline (Day-1).
11. Those who test positive for urine drugs or have a history of drug abuse or use of drugs in the past five years.
12. +Positive for Treponema pallidum antibodies, hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies or human immunodeficiency virus antibodies.
13. Those who is diagnosed as tuberculosis or have a history of non-tuberculous mycobacterial infections
14. Have a serious disease of the blood system or any disease that can cause hemolysis or instability of red blood cells, such as malaria, hemolytic anemia, etc..
15. At the time of screening, clinically significant gastrointestinal, liver or kidney abnormalities known abnormal which likely to affect drug intake, transport, absorption, distribution, metabolism or excretion.
16. Ingested any food or beverage containing caffein, or other xanthine-rich food or food that can induce or inhibit liver metabolic enzymes and beverages made from it within 48 hours before taking the study drug, or food or beverages containing alcohol, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.
17. Those who Can not tolerate venous puncture blood collection or faint blood needle.
18. Has special requirements for diet and cannot comply with a unified diet.
19. By the investigator's decision, other factors may affect the study results and interfere with his/her participation in the study process.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

94 participants in 5 patient groups, including a placebo group

ARD-885 Tablets (Multiple Administration Dose, cohort B1~B3)

Experimental group

Description:

ARD-885 Tablets, 25 mg/50 mg/100 mg, once a day(QD), from Day1\~Day7

Treatment:

Drug: ARD-885 Tablets

ARD-885 tablet (Single Administration Dose, cohort A0~A7)

Experimental group

Description:

ARD-885 Tablets, 5/10/30/60/100/150/200/250 mg，a single dose on Day1

Treatment:

Drug: ARD-885 Tablets

ARD-885 Placebo tablet (Single Ascending Dose, cohort A1~A7)

Placebo Comparator group

Description:

ARD-885 Placebo tablet, a single dose on Day1

Treatment:

Drug: ARD-885 Placebo Tablet

ARD-885 Tablets (Food Effect, cohort C1~C2)

Experimental group

Description:

ARD-885 tablets, 50mg, a single dose on Day1 and Day7, fed or fasted crossover

Treatment:

Drug: ARD-885 Tablets

ARD-885 Placebo Tablets (Multiple Administration Dose, cohort B1~B3)

Placebo Comparator group

Description:

ARD-885 Placebo tablets, once a day(QD), from Day1\~Day7

Treatment:

Drug: ARD-885 Placebo Tablet