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Immune System DiseasesPhase 1NCT03161288

A Study of KY1005 in Healthy Volunteers

A Phase 1 study testing KY1005 in people with Immune System Diseases, run by Kymab Limited at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single and multiple ascending dose, placebo-controlled, double-blind, Phase 1 study to evaluate the safety and tolerability of KY1005 in healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Immune System Diseases
What is being tested?
KY1005
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteNetherlands
Study dates
29 May 2017to 30 Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects must fulfil all of the following criteria for entry into the study.
  • Volunteer to participate in the clinical trial and provide signed informed consent.
  • Male, aged 18 to 45 years.
  • Subjects with a female spouse/partner of childbearing potential must agree to use effective birth control starting at screening and continuing throughout the clinical study period and for a period of up to 6 months after study completion.
  • Cohorts 4 to 8: previous immunisation with tetanus toxoid (TT) but not within 6 months prior to the screening visit as reported by the volunteer.
  • Cohorts 4 to 8: anti-TT immunoglobulin G (IgG) response > 0.1 IU/mL and ≤ 50 IU/mL at screening.

Who cannot join

  • Subjects fulfilling any of the following exclusion criteria are not eligible for entry into the study.
  • Experiencing a clinically significant, chronic or acute infection requiring treatment at screening or prior to first IMP administration.
  • A body weight of ≤ 60.0 kg or ≥ 120.0 kg.
  • A body mass index ≤ 18.0 or ≥ 30.0 kg/m2.
  • History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system or metabolic/endocrine system or suffered from other disease that in the opinion of the principal investigator (or medically qualified designee) may make participation unsafe for the subject or interfere with trial evaluations or otherwise considered clinically significant.
  • History of immunological abnormality (e.g., immune suppression, severe allergy or anaphylaxis) that in the opinion of the principal investigator (or medically qualified designee) may make participation unsafe for the subject or interfere with trial evaluations or otherwise considered clinically significant.
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  • History of malignancy, or known current malignancy.
  • Leukocyte absolute value < 3.50 × 10^9/L or > 9.50 × 10^9/L, neutrophil absolute value < 1.8 × 10^9/L, platelet counts < 100 × 10^9/L, haemoglobin < 12.0 g/dL.
  • Taken part in other clinical trials within 3 months of screening for this study or > four trials in the year preceding the first IMP administration.
  • Donated or lost more than 500 mL of blood or plasma within 3 months of screening.
  • Prescription drug taken within 2 weeks of screening or likely to be taken during the trial.
  • Live immunisation within 3 months of screening or plans to receive such immunisation during the clinical trial or for a period of 6 months after the end of the trial.
  • Taking or likely to take over-the-counter medication, including herbal medicines, that in the opinion of the principal investigator (or medically qualified designee) may make participation unsafe for the subject or interfere with trial evaluations.
  • Hepatitis B surface antigen, Hepatitis C antibody, or Human Immunodeficiency Virus positive.
  • History of or current drug or substance abuse considered significant by the principal investigator (or medically qualified designee) including a positive urine drug screen.
  • Current smoker and/or regular user of other nicotine-containing products (e.g., patches).
  • Average consumption of more than 14 units of alcohol/week.
  • Clinically significant abnormal screening values in clinical (electrocardiograms (ECGs), vital signs, physical examination) and laboratory tests in the opinion of the principal investigator (or medically qualified designee).
  • Cannot communicate adequately or cannot commit to full participation in all trial procedures.
  • For Cohorts 4 to 8:
  • Confirmed previous exposure to immunocyanins, such as keyhole limpet haemocyanin (KLH);
  • Known allergy to thiomersal or other components of Tetanus vaccine or Immucothel®;
  • History of schistosomiasis.
  • Any observation that, in the opinion of the principal investigator (or medically qualified designee) makes the subject unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Centre for Human Drug Research

    Leiden

Other trials in Netherlands

About this study

Official title: A Single and Multiple Ascending Dose, Placebo-Controlled, Double-Blind, Phase 1 Study of KY1005 in Healthy Volunteers

This is a single and multiple ascending dose, placebo-controlled, double-blind, Phase 1 study to evaluate the safety and tolerability of KY1005 in healthy volunteers.

Being tested
KY1005, Placebo
Medical subject headings
Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KY1005Drug

    A human anti-OX40 ligand monoclonal antibody

  • PlaceboDrug

    Matched placebo

Study groups in NCT03161288
Study groupRoleWhat they receive
Cohorts 1-3ExperimentalHealthy volunteers will receive single rising doses of KY1005 or placebo
Receives: Drug: KY1005; Drug: Placebo
Cohorts 4-8ExperimentalHealthy volunteers will receive multiple rising doses of KY1005 or placebo
Receives: Drug: KY1005; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of all treatment-related adverse events

    Measured: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.

  2. Changes in vital signs (as a measure of safety and tolerability)

    Measured: Cohorts 1 to 3: from pre-first infusion up to day 113. Cohorts 4 to 8: from pre- first infusion up to day 92.

  3. Changes in laboratory safety data (as a measure of safety and tolerability)

    Measured: Cohorts 1 to 3: from pre-first infusion up to day 113. Cohorts 4 to 8: from pre-first infusion up to day 92.

  4. Changes in anti-viral antibody levels and viral DNA (as a measure of safety and tolerability)

    Measured: Cohorts 1 to 3: from pre-first infusion up to day 113. Cohorts 4 to 8: from pre-first infusion up to day 92.

  5. Changes in acute cytokines (as a measure of safety and tolerability)

    Measured: Cohorts 1 to 3: from pre-first infusion up to day 113. Cohorts 4 to 8: from pre-first infusion up to day 92.

  6. Changes in electrocardiograms (as a measure of safety and tolerability)

    Measured: Cohorts 1 to 3: from pre-first infusion up to day 113. Cohorts 4 to 8: from pre-first infusion up to day 92.

Secondary outcomes (8)

  1. Maximum observed serum concentration (Cmax) following the first, second and third infusions for each KY1005 dose/dosing group

    Measured: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.

  2. Time to maximum observed serum concentration (tmax) following the first, second and third infusions for each KY1005 dose/dosing group

    Measured: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.

  3. Trough concentrations (Cmin) following the first and second infusions and 28 days after the third infusion

    Measured: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.

  4. Areas under the plasma concentration-time curves (AUC)

    Measured: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.

  5. Clearance (CL)

    Measured: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.

  6. Apparent volume of distribution during terminal phase (Vz)

    Measured: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.

  7. Apparent volume of distribution at steady state (Vss)

    Measured: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.

  8. Half-life (t½)

    Measured: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2017
  2. Study start29 May 2017
  3. Primary completion30 Mar 2018
  4. Study completion30 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03161288
Sponsor's protocol ID
KY1005-CT01
Status last verified
Aug 2019
First submitted
11 May 2017
Last updated
29 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Saghari M, Gal P, Gilbert S, Yateman M, Porter-Brown B, Brennan N, Quaratino S, Wilson R, Grievink HW, Klaassen ES, Bergmann KR, Burggraaf J, van Doorn MBA, Powell J, Moerland M, Rissmann R. OX40L Inhibition Suppresses KLH-driven Immune Responses in Healthy Volunteers: A Randomized Controlled Trial Demonstrating Proof-of-Pharmacology for KY1005. Clin Pharmacol Ther. 2022 May;111(5):1121-1132. doi: 10.1002/cpt.2539. Epub 2022 Mar 1.

    PubMed 35092305

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KY1005 in people with Immune System Diseases, run by Kymab Limited at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of all treatment-related adverse events (time frame: Cohorts 1 to 3: up to day 113. Cohorts 4 to 8: up to day 92.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03161288, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.

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