Trial Outcomes & Findings for Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG) (NCT NCT03624946)

NCT ID: NCT03624946

Last Updated: 2024-03-18

Results Overview

Number of subjects with of adverse events by severity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

Up to Day 85

Results posted on

2024-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Zika Virus Immune Globulin (ZIKV-IG) Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG). Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Overall Study STARTED	19	11
Overall Study COMPLETED	19	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Zika Virus Immune Globulin (ZIKV-IG) Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG). Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 Participants Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=11 Participants Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=93 Participants	11 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	35 years n=93 Participants	30 years n=4 Participants	33.5 years n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	7 Participants n=4 Participants	22 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=93 Participants	8 Participants n=4 Participants	26 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants	8 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment Canada	19 participants n=93 Participants	11 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to Day 85

Population: Safety population includes all subjects who received any amount of study treatment (ZIKV-IG or placebo).

Number of subjects with of adverse events by severity.

Outcome measures

Outcome measures
Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 Participants Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=11 Participants Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Number of Subjects With Adverse Events. Subjects with a serious adverse event	0 participants	0 participants
Number of Subjects With Adverse Events. Subjects with an adverse event	12 participants	8 participants
Number of Subjects With Adverse Events. Subjects with a severe adverse event	0 participants	0 participants
Number of Subjects With Adverse Events. Subjects with an adverse event assessed as related	8 participants	3 participants

SECONDARY outcome

Timeframe: 0-2 hours predose to Day 85 postdose

Population: PK population included all subjects who received ZIKV-IG with adequate number of PK samples (a suitable pre-dose sample and at least one measurable post-dose sample) and PK population with subject 01-127 removed to permit comparison of the concentrations with and without the outlying subject.

Maximum observed serum concentration of Zika Virus Immune Globulin (ZIKV-IG)

Outcome measures

Outcome measures
Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 Participants Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=18 Participants Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Maximum Concentration (Cmax)	171.8 U/mL Geometric Coefficient of Variation 33.9	182.3 U/mL Geometric Coefficient of Variation 21.3

SECONDARY outcome

Timeframe: 0-2 hours predose up to Day 85 postdose

Time at which maximum serum concentration of Zika Virus Immune Globulin (ZIKV-IG) occurs.

Outcome measures

Outcome measures
Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 Participants Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=18 Participants Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Time to Maximum Concentration (Tmax)	6.1 hours Standard Deviation 16.4	2.3 hours Standard Deviation 1.0

SECONDARY outcome

Timeframe: 0-2 hours predose to Day 85 postdose

Area under the concentration-time curve from time 0 to the last quantifiable serum Zika Virus Immune Globulin (ZIKV-IG) concentration.

Outcome measures

Outcome measures
Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 Participants Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=18 Participants Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Area Under the Curve Up to Last Quantifiable Concentration (AUC0-t)	66304 h*U/mL Geometric Coefficient of Variation 19.2	67221 h*U/mL Geometric Coefficient of Variation 18.8

SECONDARY outcome

Timeframe: 0-2 hours predose up to Day 85 postdose

Area under the concentration-time curve from time 0 to the last quantifiable serum Zika Virus Immune Globulin (ZIKV-IG) concentration, plus the area extrapolated to infinity.

Outcome measures

Outcome measures
Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 Participants Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=18 Participants Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Area Under the Curve Extrapolated to Infinity (AUC0-inf)	76170 h*U/mL Geometric Coefficient of Variation 18.4	77224 h*U/mL Geometric Coefficient of Variation 17.9

SECONDARY outcome

Timeframe: 0-2 hours predose up to Day 85 postdose

Total body clearance of Zika Virus Immune Globulin (ZIKV-IG) following IV administration.

Outcome measures

Outcome measures
Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 Participants Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=18 Participants Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Clearance (CL)	6.966 mL/h Geometric Coefficient of Variation 18.4	6.871 mL/h Geometric Coefficient of Variation 17.9

SECONDARY outcome

Timeframe: 0-2 hours predose up to Day 85 postdose

Apparent first order terminal elimination half-life of Zika Virus Immune Globulin (ZIKV-IG).

Outcome measures

Outcome measures
Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 Participants Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=18 Participants Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Half-Life (t1/2)	674.3 hours Geometric Coefficient of Variation 15.9	674.7 hours Geometric Coefficient of Variation 16.4

SECONDARY outcome

Timeframe: 0-2 hours predose up to Day 85 postdose

Volume of distribution of Zika Virus Immune Globulin (ZIKV-IG) following IV administration.

Outcome measures

Outcome measures
Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 Participants Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=18 Participants Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Volume of Distribution (Vz)	6776.8 mL Geometric Coefficient of Variation 20.4	6687.7 mL Geometric Coefficient of Variation 20.1

Adverse Events

Zika Virus Immune Globulin (ZIKV-IG)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo (Saline Solution)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Jason Richardson, Senior Scientist, Clinical Research

Emergent BioSolutions Canada Inc.

Phone: 204-275-4266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee CRO agrees that Emergent shall have the exclusive right to publish the results of each Study under a Task Order, including all Work Product relating thereto, and that such results may not be published or otherwise disseminated by CRO.
Publication restrictions are in place

Restriction type: OTHER

Measure	Zika Virus Immune Globulin (ZIKV-IG) n=19 participants at risk Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Zika Virus Immune Globulin (ZIKV-IG): Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.	Placebo (Saline Solution) n=11 participants at risk Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Placebo: Placebo is a normal saline solution (0.9% sodium chloride).
Nervous system disorders Headache	21.1% 4/19 • Number of events 4 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 2 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Nervous system disorders Dizziness	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	18.2% 2/11 • Number of events 2 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Nervous system disorders Dysgeusia	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Nervous system disorders Paraesthesia	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 2 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Gastrointestinal disorders Abdominal distension	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Gastrointestinal disorders Abdominal pain lower	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Gastrointestinal disorders Diarrhoea	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Gastrointestinal disorders Dry mouth	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Gastrointestinal disorders Tongue pigmentation	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
General disorders Fatigue	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	18.2% 2/11 • Number of events 2 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
General disorders Peripheral swelling	10.5% 2/19 • Number of events 2 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
General disorders Catheter site hypoaesthesia	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
General disorders Feeling of body temperature change	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
General disorders Influenza like illness	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
General disorders Vessel puncture site bruise	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Investigations Aspartate aminotransferase increased	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Investigations Blood lactate dehydrogenase increased	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Investigations Alanine aminotransferase increased	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Investigations Blood creatine phosphokinase increased	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Investigations Myoglobin blood increased	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Infections and infestations Abdominal abscess	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Infections and infestations Hordeolum	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Infections and infestations Oral herpes	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Infections and infestations Pharyngitis streptococcal	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Infections and infestations Upper respiratory tract infection	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.5% 2/19 • Number of events 2 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Reproductive system and breast disorders Menorrhagia	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Skin and subcutaneous tissue disorders Rash	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Skin and subcutaneous tissue disorders Skin lesion	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Blood and lymphatic system disorders Lymphadenopathy	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Eye disorders Vision blurred	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Injury, poisoning and procedural complications Arthropod bite	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Psychiatric disorders Hypervigilance	0.00% 0/19 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	9.1% 1/11 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.
Renal and urinary disorders Haematuria	5.3% 1/19 • Number of events 1 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.	0.00% 0/11 • Adverse events were collected from Day 1 (Dosing Day) through Day 85 or early withdrawal. Adverse events were unsolicited.