ANX-042 Healthy Volunteer Dose Escalation Study

Each participant received a total of two, approximately 12-hour continuous infusions of
ANX-042 and one 12-hour continuous infusion of placebo, with a 36-hour washout period between
treatments.

This study was conducted by Anexon, Inc. at Celerion, in Lincoln, Nebraska.

Inclusion Criteria:

- Men or women of non-reproductive potential (WNRP)

- Men must be willing to use effective contraception and not donate sperm for up to
90 days after the final dose of study drug

- Women must be of non-reproductive potential defined as a history of surgical
sterilization or postmenopausal status (that is, greater than ( >) 50 years of
age with >12 months amenorrhea while not using hormonal contraceptives or >50
years of age with 6-12 months of amenorrhea and follicle stimulating hormone
(FSH) level >40 international unit/liter (IU/L)

- Good health status, physically active without cardio-respiratory limitations and
minimal concomitant medications as determined by medical history and physical
examination

- Able and willing to comply with study procedures, including controlled sodium (Na)
intake and restriction of caffeine and tobacco product

- Have given written informed consent prior to the initiation of any study procedures

Exclusion Criteria:

- History of cardiovascular disease, unexplained syncope, postural tachycardia syndrome
or frequent postural hypotension

- History or current evidence of respiratory, hepatic, renal, gastrointestinal,
endocrine, hematological or neurological disorders that would constitute a risk when
taking the study medication or interfere with the interpretation of data

- Clinically significantly abnormal clinical laboratory results (including Hepatitis B,
Hepatitis C and Human Immunodeficiency Virus (HIV) serology) or physical examination
results (confirmed by repeat measurement, if appropriate) that, in the opinion of the
Investigator, would constitute a risk when taking the study medication or interfere
with the interpretation of data

- Abnormal orthostatic Blood Pressure/Heart Rate (BP/HR) response at screening as
defined by:

- Systolic Blood Pressure (BP) decrease >20 millimeters of mercury (mmHg)

- Diastolic BP decrease >10 mmHg, or

- HR increase >25 beats per minute (bpm) and to a level above 100 bpm

- One or two supine values must be obtained between 8 and 10 minutes of supine rest. One
or two upright values must be obtained between 3 and 5 minutes upright with the arm
passively supported to maintain the brachial artery at heart level

- Abnormal 12-lead electrocardiogram (ECG) that interferes with proper measurement of
QT-interval or, in the opinion of the Investigator, increases the risk of
participating in the study

- Elevated BP (>140/90 mmHg) in any posture, confirmed by repeat measurement

- Current use (within 7 days of first dosing) or expected need for concomitant
medications with hemodynamic effects including: non-steroidal anti-inflammatory drugs
(NSAIDS), decongestants, BP medications, diuretics, monoamine oxidase inhibitors,
norepinephrine uptake inhibitors (for example, attention-deficit disorder medications,
anti-depressants) and erectile dysfunction medications. Medications with low
likelihood of hemodynamic or renal effects are permitted (for example, acetaminophen,
vitamins, stable thyroid hormone, gastritis therapies, antihistamines, topical
medications, et cetera) after approval by the Investigator

- Evidence of current or recent use of known drugs of abuse and/or positive findings on
urinary drug screening

- History of an average weekly alcohol intake that exceeds 21 units per week (1 unit
equal to (=) 12 ounces (oz) or 360 milliliters (mL) of beer; 5 oz or 150 mL of wine;
1.5 oz or 45 mL of distilled spirits), or are unwilling to stop alcohol consumption
for the duration of the study

- History of regular smoking of >5 cigarettes, cigars and/or pipe bowls of tobacco per
day

- Known allergies to nesiritide (Natrecor)

- History of blood donation of >500 mL within one month, or plasma donation within 14
days, of first dosing

- Are currently enrolled in, or have completed or discontinued within the last 30 days
from, a clinical trial involving an investigational product or are concurrently
enrolled in any other type of medical research judged not to be scientifically or
medically compatible with this study

- Are investigator site personnel directly affiliated with this study or their immediate
family members. Immediate family is defined as a spouse, parent, child or sibling,
whether biological or legally adopted

- Are Lilly or Anexon employees or employees of any third-party organization (TPO)
involved with the study that require exclusion of their employees