A Phase 1 interventional study of KP001 and Placebo in Acute Allergic Reaction and Anaphylaxis, sponsored by Kokua Pharma Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by Kokua Pharma Inc. · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of several KP001 dose regimens to identify a treatment regimen with a PK profile that safely meets or exceeds the PK profile of existing injected epinephrine products. The main questions it aims to answer are:
Participants will:
This study is a 5-period crossover design to evaluate the safety, tolerability, and PK of KP001 compared to placebo and to evaluate for the potential for carryover effect (Arms A \& B). An exploratory 3rd arm (Arm C) will evaluate the PK of KP001 when breath holding to replicate an unconscious patient situation, and results will be used to design a possible future breath-holding study. Sequence will be either AABBC or BBAAC. Two doses of KP001 (0.25 mg or 1.0 mg) or placebo will be administered to 16 subjects (12 active and 4 placebo subjects) on two separate occasions, separated by a 1-week washout period. A third arm will evaluate one dose of KP001 (0.5 mg) PK while breath holding.
The total study duration for subjects will be up to 11 weeks, consisting of:
100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 50 interventional studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →This is the only study on the registry with Kokua Pharma Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive two sets of treatments of 0.25 mg (2 inhalations of 0.125 mg each time) of KP001 (or matching placebo) over 2 visits separated by a 1-week washout period. Investigational Product (IP) will be delivered as 1 set of 2 inhalations (2 total) spaced approximately 10 seconds apart. Subjects will repeat Arm therefore total dose in mg for Arm = 0.5 mg.
Drug: KP001 · Drug: Placebo
Subjects will receive four sets of treatments of 0.25 mg (2 inhalations of 0.125 mg each time), totaling 1.0mg of KP001 (or matching placebo) over 2 visits separated by a 1-week washout period. IP will be delivered as 4 sets of 2 inhalations (8 total) spaced approximately 10 seconds apart. Each set of 2 inhalations will be spaced approximately 2 minutes apart. Subjects will repeat Arm therefore total dose in mg for Arm = 2.0 mg.
Drug: KP001 · Drug: Placebo
Subjects will receive 0.5 mg of KP001 (or matching placebo) delivered as 4 rapidly administered sequential inhalations (4 total), dosed approximately 5 seconds apart, spaced over approximately 15 seconds while holding their breath during the entire dosing treatment and after treatment for a total minimum 30 seconds (or longer) before exhaling. Total dose in mg for Arm = 0.5 mg.
Drug: KP001 · Drug: Placebo
Epinephrine Inhalation Aerosol (0.125 mg per inhalation)
Matched Placebo control (KP001 vehicle only)
The maximal observed plasma concentration (Cmax)
Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.
Time frame: 1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29
Area under the concentration-time curve from time zero to last measurable concentration (AUC0-t)
Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.
Time frame: 1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.
Time frame: 1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29
Time when the maximal plasma concentration is observed (Tmax)
Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.
Time frame: 1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29
Rate at which drug is removed from the body (Kel)
Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.
Time frame: 1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29
Half-life of drug (T1/2)
Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.
Time frame: 1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29
Plan to share: Yes — All individual participant data collected during the trial, after deidentification
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Immediately after publication, and for a period of 5 years.
Access criteria: Any purpose. URL to be added.
No publications or documents are linked to this record.
Ran from May 2025 to primary completion in Jul 2025, 2 months.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: KP-001