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NCT Number: NCT05006521

Single and Multiple Ascending Dose Study of KN-002

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.

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Key information

Conditions

Asthma COPD

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 18 - 55 years old
  • Willing and able to give informed consent and comply with the study
  • Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
  • Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
  • Pre-bronchodilator FEV1 ≥ 70 and ≥80% for Part 1 and Part 2 participants, respectively
  • Pre-Bronchodilator FEV1 ≥50% predicted and ≤100% for Part 3
  • Post Bronchodilator FEV1 ≥40 and ≤ 85% for Part 4

Exclusion criteria

  • Clinically significant laboratory test abnormalities
  • Clinically significant abnormal blood pressure and/or pulse rate
  • Resting ECG clinically significant abnormalities
  • Respiratory tract infection within 6 weeks of screening
  • Positive test for active COVID-19 within 2 days prior to administration of IMP

Treatment and study plan

KN-002

Drug

KN-002 dry powder inhaler

Primary outcomes

  1. Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events

    Time frame: Day 1 to 17

    To assess the safety and tolerability of KN-002 via the assessment of the number, severity and type of treatment emergent adverse events post single and repeat dose administration to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD

Secondary outcomes

  1. Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC)

    Time frame: Day 1 to 17

    KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:

  2. Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax)

    Time frame: Day 1 to 17

    KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:

  3. Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels

    Time frame: Day 1 to 17

    Change of fractional exhaled nitric oxide (FeNO) levels after repeated dosing to patients with mild asthma, moderate to severe asthma and COPD

Sponsors and collaborators

Lead sponsor

Kinaset Therapeutics Inc

Industry

Registry information

Official study title

Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, PK, and PD of Single Ascending Doses of KN-002 in Healthy Subjects and Multiple Ascending Doses of KN-002 in Subjects With Mild Asthma, Moderate-Severe Asthma and COPD

Acronym: KN-002

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 16, 2021
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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