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A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants

ConditionsParoxysmal Nocturnal Hemoglobinuria, PNHComplement-mediated Kidney Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShenzhen Kangzhe Biotechnology Co., Ltd.

About this trial

This study is a first-in-human (FIH) trial of CMS-D017 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple ascending dose (MAD) study (referred to as Part 2 MAD). The study aims to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of CMS-D017 capsules following single and multiple oral administrations in healthy Chinese adult participants.

Both parts of the study are designed as randomized, double-blind, placebo-controlled, sequential cohort trials. Part 1 SAD plans to include 6 dose cohorts, with 8 participants per cohort (6 receiving CMS-D017 and 2 receiving placebo), for a total of 48 participants. Part 2 MAD plans to include 4 dose cohorts, with 10 participants per cohort (8 receiving CMS-D017 and 2 receiving placebo), for a total of 40 participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Voluntarily participates in this study and signs the informed consent form.

Able to communicate well with the investigator and understands and complies with all requirements and restrictions of this study, and is able to complete the study in accordance with the protocol.

Aged 18-55 years (inclusive, as of the day of signing the informed consent form), male or female.

Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive) at screening, with females weighing ≥ 45.0 kg and males weighing ≥ 50.0 kg.

Disqualifiers

History of severe allergies, including food allergies, or allergy to the study drug or its components.

Significant history or clinical manifestations of cardiovascular, respiratory, digestive, urogenital, hematologic, endocrine and metabolic, rheumatic, immunologic, neuropsychiatric, or musculoskeletal diseases requiring medication and/or other treatments (including dietary restrictions and physical therapy), as deemed unsuitable for participation in this study by the investigator.

Any condition that may affect drug absorption, including but not limited to: malabsorption syndrome, inflammatory bowel disease, celiac disease, gastrectomy, cholecystectomy, bowel resection (except appendectomy).

History of meningococcal infection or first-degree relatives with history of meningococcal infection.

Trial design

Design model

Sequential

Treatments tested in this trial

  • CMS-D017 Capsule

    Drug

    healthy participant

  • CMS-D017 Placebo Capsule

    Drug

    healthy participant

  • CMS-D017 Capsule

    Drug

    healthy subject

  • CMS-D017 Placebo Capsule

    Drug

    healthy subject

Treatment groups

88 Participants
are divided into 4 treatment groups
Group A: Single Dose Escalation of CMS-D017Experimental treatment 1 intervention
Group B: Single Dose Escalation- placeboPlacebo comparator 1 intervention
Group C: Multiple Dose Escalation of CMS-D017Experimental treatment 1 intervention
Group D: Multiple Dose Escalation of placeboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of CMS-D017 -Adverse events

Monitoring of adverse events

Time frame
Up to 23 days

Secondary outcomes

1

Tmax

Time to reach maximum observed plasma concentration

Time frame
Up to 16 days
2

Rac_Cmax

Accumulation ratio based on Cmax

Time frame
Up to 16 days
3

Cmax

Maximum observed concentration

Time frame
Up to 16 days
4

AUC

Area under the curve

Time frame
Up to 16 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Kangzhe Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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