A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT03906006
• Recruitment Status: Completed
• First Posted: April 8, 2019
• Last Update Posted: July 29, 2020
• Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Study Description

Brief Summary:

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ABP-671 administered orally in healthy volunteers.

Condition or disease	Intervention/treatment	Phase
Gout; Hyperuricemia	Drug: ABP-671; Other: Placebo	Phase 1

Detailed Description:

Primary Objectives:

• To assess the safety and tolerability of single ascending oral doses of ABP-671 in Healthy Volunteers (HVs).

Secondary Objectives:

• To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of single ascending oral doses of ABP-671 in HVs.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of ABP-671 in Healthy Volunteers in the United States
• Actual Study Start Date: October 17, 2018
• Actual Primary Completion Date: June 20, 2019
• Actual Study Completion Date: June 20, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: ABP-671, Cohort 1-; ABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).	Drug: ABP-671; Drug: ABP-671, single oral dose; Other: Placebo; Other: Placebo, single oral dose
Experimental: ABP-671, Cohort 2-; ABP-671, Cohort 2 participants will receive 0.1 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).	Drug: ABP-671; Drug: ABP-671, single oral dose; Other: Placebo; Other: Placebo, single oral dose
Experimental: ABP-671, Cohort 3-; ABP-671, Cohort 3 participants will receive 0.5 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).	Drug: ABP-671; Drug: ABP-671, single oral dose; Other: Placebo; Other: Placebo, single oral dose
Experimental: ABP-671, Cohort 4-; ABP-671, Cohort 4 participants will receive 1.0 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).	Drug: ABP-671; Drug: ABP-671, single oral dose; Other: Placebo; Other: Placebo, single oral dose

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events [ Time Frame: baseline to 7 days ]
   Incidence of adverse events
2. Maximum tolerable dose [ Time Frame: baseline to 7 days ]
   Maximum tolerable dose

Secondary Outcome Measures :

1. Peak plasma concentration [ Time Frame: baseline to 72 hours ]
   Peak plasma concentration
2. half-life [ Time Frame: baseline to 72 hours ]
   half-life
3. area under the curve [ Time Frame: baseline to 72 hours ]
   area under the curve
4. volume of distribution [ Time Frame: baseline to 72 hours ]
   volume of distribution
5. level of serum and urine uric acid [ Time Frame: baseline to 72 hours ]
   level of serum and urine uric acid
6. level of serum and urine creatinine [ Time Frame: baseline to 72 hours ]
   level of serum and urine creatinine

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria

1. Healthy (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, and vital signs.
2. Participants serum uric acid level at screening ≥ 4.0 mg/dL to ≤ 5.5 mg/dL for males, and ≥ 4.0 mg/dL to ≤ 5.0 mg/dL for females.
3. Participants must have a body mass index (BMI) between 18 and 32 kg/m2 and a body weight of 50 kg or higher.
4. Participants must have normal blood chemistry or results considered not clinically significant by the investigator including electrolytes, alkaline phosphatase, total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, uric acid, creatinine, blood urea nitrogen (BUN), and glucose at Screening Visit and at Pre-dose Visit.
5. Participants are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.

Exclusion Criteria

1. Participants with any history or clinical manifestations of significant metabolic, hematological, pulmonary, including latent tuberculosis, cardiovascular, gastrointestinal including cholecystectomy, neurologic, hepatic, renal, urological, or psychiatric disorders.
2. Participants who have any history or suspicion of kidney stones.
3. Participants who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing. Females who have received hormone replacement therapy (HRT) within 28 days prior to dosing.
4. Women who are pregnant or breastfeeding.

Contacts and Locations

Locations

United States, Arizona

Celerion

Tempe, Arizona, United States, 85283

Sponsors and Collaborators

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Danielle Armas, M.D.; Celerion

More Information

• Responsible Party: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03906006
• Other Study ID Numbers: ABP-671-101
• First Posted: April 8, 2019
• Last Update Posted: July 29, 2020
• Last Verified: July 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.:

gout; hyperuricemia

Additional relevant MeSH terms:

Hyperuricemia; Pathologic Processes